UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057127 |
|---|---|
| Receipt number | R000065221 |
| Scientific Title | Prediction of tacrolimus blood concentration by CYP3A5 gene polymorphism |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/02/25 15:49:04 |
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Basic information
Public title
Prediction of tacrolimus blood concentration by CYP3A5 gene polymorphism
Acronym
Prediction of tacrolimus blood concentration by CYP3A5 gene polymorphism
Scientific Title
Prediction of tacrolimus blood concentration by CYP3A5 gene polymorphism
Scientific Title:Acronym
Prediction of tacrolimus blood concentration by CYP3A5 gene polymorphism
Region
| Japan |
Condition
Condition
Patients taking tacrolimus or who are planning to take it for kidney transplant etc.
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study aims to develop a method for predicting tacrolimus blood concentrations by examining variations in CYP3A5 genetic polymorphisms and to establish an approach for achieving target blood concentrations efficiently within a short timeframe.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Predicting tacrolimus blood concentrations according to CYP3A5 gene polymorphisms
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Evaluate CYP3A5 genetic polymorphisms
Measure blood and urinary concentrations of tacrolimus and metabolites periodically up to 24 hours after dosing.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients currently taking tacrolimus or who are planning to take tacrolimus
Key exclusion criteria
non
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | KENGO |
| Middle name | |
| Last name | FURUICHI |
Organization
Kanazawa Medical University
Division name
Department of Nephrology
Zip code
920-0293
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
076-286-2211
furuichi@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | KENGO |
| Middle name | |
| Last name | FURUICHI |
Organization
Kanazawa Medical University
Division name
Department of Nephrology
Zip code
920-0293
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
076-286-2211
Homepage URL
furuichi@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committee, Kanazawa Medical University
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
Tel
076-286-2211
tiken@kanazawa-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 25 | Day |
Last modified on
| 2025 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065221
